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This study was terminated due to recruitment futility resulting from the significant impact of the COVID-19 pandemic to our intended study population and facility personnel.
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Single sequence clinical study designed to evaluate the effectiveness of B. Braun PA on improved clinical outcomes, indwell time and first stick success of PIVC using B. Braun Peripheral Advantage (PA) by Registered Nurses (RNs).
The study will be conducted in the Emergency Department (ED) and/or Medical Surgical (MS) floor(s)/unit(s) in multiple hospitals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 Baseline | Active Comparator | Study site to use standard of care PIVC device(s) and procedure(s) on patients. |
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| Stage 2 Education | Other | RN education and training in the use of B. Braun PIVC products, devices and procedures. |
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| Stage 3 Run-In | Other | Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting. |
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| Stage 4 Post-Education | Other | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. Braun Peripheral Advantage (PA) Program | Device | B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
| Measure | Description | Time Frame |
|---|---|---|
| Complications Associated With PIVC Use | [Planned] Outcome: Evaluate the impact of B. Braun Peripheral Advantage (PA) Program on the number of stick attempts with complications associated with PIVC use. Due to the early termination in Stage 1, no data were collected from Stages 2 through 4 to perform comparative analyses. | Through study completion, an estimate of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Indwell Time | Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion. | Up to 48 hours and between 48 and 168 hours |
| First Attempt Success Rates (First Stick Success) |
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Inclusion Criteria:
Subjects must meet all of the following Inclusion Criteria:
Exclusion Criteria:
Subjects must not meet any of the following Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camilla M Jaekel, RN | Mayo Clinic - La Crosse, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | La Crosse | Wisconsin | 54601 | United States |
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Study was terminated during Stage 1 for recruitment futility. Stages 2 through 4 were not conducted.
44 subjects (patients) were consented in Stage 1, however one subject failed inclusion/exclusion criteria. Thus 43 subjects received study procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 Baseline | Study site to use standard of care PIVC device(s) and procedure(s) on patients. For this study, PARTICIPANTS were defined as patients whom the procedures were performed on; RNs were the individuals performing the procedures. Hospital Standard of Care: Standard of Care for PIVC access per hospital protocol |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2021 | Jun 7, 2022 |
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The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.
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| Hospital Standard of Care | Device | Standard of Care for PIVC access per hospital protocol |
|
Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion.
| Initial needle stick (baseline) |
| Aggregate Costs Associated With Catheter Insertion | Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion. | Through study completion, an estimate of 1 year |
| Stage 2 Education |
RN education and training in the use of B. Braun PIVC products, devices and procedures. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education **THIS PHASE WAS NOT CONDUCTED** |
| FG002 | Stage 3 Run-In | Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education **THIS PHASE WAS NOT CONDUCTED** |
| FG003 | Stage 4 Post-Education | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education **THIS PHASE WAS NOT CONDUCTED** |
| COMPLETED |
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| NOT COMPLETED |
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Study terminated during stage 1 for recruitment futility. Stages 2 through 4 were not conducted.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 Baseline | Study site to use standard of care PIVC device(s) and procedure(s) on patients. Hospital Standard of Care: Standard of Care for PIVC access per hospital protocol |
| BG001 | Stage 2 Education | RN education and training in the use of B. Braun PIVC products, devices and procedures. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
| BG002 | Stage 3 Run-In | Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
| BG003 | Stage 4 Post-Education | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complications Associated With PIVC Use | [Planned] Outcome: Evaluate the impact of B. Braun Peripheral Advantage (PA) Program on the number of stick attempts with complications associated with PIVC use. Due to the early termination in Stage 1, no data were collected from Stages 2 through 4 to perform comparative analyses. | Study stopped due to recruitment futility. Stages 2 through 4 were not conducted. | Posted | Count of Units | Stick Attempts | Through study completion, an estimate of 1 year | Stick Attempts | Stick Attempts |
|
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| Secondary | Catheter Indwell Time | Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion. | Study stopped due to recruitment futility. Stages 2 through 4 were not conducted. Of the 43 patients with attempted needle sticks, only 35 were successful. | Posted | Median | Full Range | Hours | Up to 48 hours and between 48 and 168 hours |
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| Secondary | First Attempt Success Rates (First Stick Success) | Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion. | Study stopped due to recruitment futility. Stages 2 through 4 were not conducted. | Posted | Count of Units | Stick Attempts | Initial needle stick (baseline) | Stick Attempts | Stick Attempts |
| |||||||||||||||||||||||||||||||||||
| Secondary | Aggregate Costs Associated With Catheter Insertion | Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion. | Data were not collected for this Outcome Measure as a consequence of not performing the assessment. Study stopped during Stage 1 due to recruitment futility. | Posted | Through study completion, an estimate of 1 year |
|
Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported).
Study stopped during Stage 1 due to recruitment futility. Stages 2 through 4 were not conducted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1 Baseline | Study site to use standard of care PIVC device(s) and procedure(s) on patients. Hospital Standard of Care: Standard of Care for PIVC access per hospital protocol | 0 | 43 | 0 | 43 | 12 | 43 |
| EG001 | Stage 2 Education | RN education and training in the use of B. Braun PIVC products, devices and procedures. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Stage 3 Run-In | Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Stage 4 Post-Education | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infiltration | General disorders | Systematic Assessment |
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| Occlusion | Product Issues | Systematic Assessment |
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| Accidental Removal | Surgical and medical procedures | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
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Due to limitations in the data collected only in Stage 1, no conclusions can be drawn on the impact of B. Braun PA Program on the incidence of complications associated with PIVC use.
The only disclosure restriction on the PI is that the sponsor can review results communications and redact proprietary information prior to public release and can embargo communications regarding trial results for a period of at least 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes (other than as described) to the communication however the embargo may be extended an additional 60 days if patent issues are involved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diana Valencia | B. Braun Medical Inc. | 610-596-2875 | diana.valencia@bbraunusa.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2021 | Jun 7, 2022 | SAP_001.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Stick Attempts |
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| OG003 | Stage 4 Post-Education | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
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| OG003 | Stage 4 Post-Education | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
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| OG003 | Stage 4 Post-Education | Study site uses B. Braun PIVC device(s) and procedure(s) on patients. B. Braun Peripheral Advantage (PA) Program: B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education |
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